Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
AbbVie124500 - 236500
IrvineFull TimeData Science
Remotely
Listed on 2 job boards, which is a stronger signal than one board alone.
regulatory affairsdigital healthregulatory strategymedical deviceall otherfdagrptglobal regulatory product team
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Job Description
📋 Description
- Develop and implement US and Canada regulatory strategic/tactical planning (RSTP) for assigned
- Collaborate with Global Regulatory Product Team to align strategies with regulatory and business
- Gather data to support filings, inquiries, and registration maintenance for commercialization.
- Lead lifecycle activities including change assessments, post-approval requirements, and FDA
- Coordinate/regulate submissions per US/Canada requirements and respond to Health Authorities.
- Present regulatory information to cross-functional teams and ensure policy compliance.
🎯 Requirements
- Advanced degree (PharmD, PhD, MS) or Regulatory certification.
- 5+ years Regulatory/R&D or related experience; medical device and digital health/software
- Experience with US/Canada regulatory strategies; FDA liaison experience a plus.
- Ability to operate in a complex, matrix environment and communicate effectively.
- Strong negotiation, problem-solving, and consensus-building skills.
🎁 Benefits
- Comprehensive benefits package and eligible for long-term incentive programs.
- Paid time off, medical/dental/vision coverage, 401(k) plans.
- AbbVie equal opportunity employer; commitment to integrity and inclusion.
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